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Premature Infant DiseaseNCT05412524

Impact of Reading on Endogenous Oxytocin System of Preterm Infants

A study testing reading in people with Premature Infant Disease and Development, Infant, run by University of Virginia at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to learn how early language exposure may be related to changes in DNA in parents and their premature infants. While a person's genetic code is determined at the time of conception, the way that some genes are expressed in the body can be changed even after an individual is born. Read more about this study

Who is it for?
Ages Up to 33 weeks
Conditions the study is for
Premature Infant Disease, Development, Infant
What is being tested?
reading
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
23 Sep 2022to Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 33 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants <33 week gestational age at birth
  • Mother must be able to visit at least once per week
  • Mother or primary caregiver must participate; father or secondary caregiver may participate as well
  • Mother must commit to minimum of 15 minutes reading at least once per week

Who cannot join

  • Infant with life-limiting conditions
  • Mother is non-English speaking
  • Illiteracy of mother

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Kelsey Sullivan, MD, 434-305-9356, ptf3df@hscmail.mcc.virginia.edu

    Santina Zanelli, MD, 434-924-2335, SZ5D@hscmail.mcc.virginia.edu

    Recruiting

Other trials in United States

About this study

The purpose of this study is to learn how early language exposure may be related to changes in DNA in parents and their premature infants. While a person's genetic code is determined at the time of conception, the way that some genes are expressed in the body can be changed even after an individual is born. These changes are called epigenetic changes. In this study, the investigators want to learn about the epigenetic changes that happen after a premature baby is born and whether a parent's interaction with their baby can influence these epigenetic changes. The investigators will look at epigenetic changes by collecting saliva samples from parents and their preterm babies, here defined as babies born at <33 weeks gestation. Specifically, the investigators will be looking at salivary levels of DNA methylation of the oxytocin receptor gene (OXTRm). The investigators will track changes in OXTRm levels over time in parents and their babies and see if these levels change in relation to how much time parents spend with their babies and how much time they spend reading to their babies. The investigators will ask mothers and, if desired, their partners to read to their babies for at least 15 minutes per week. The investigators will ask them to track time spent with the baby and reading time on a log, and will also measure word count with a commercially-available LENA device. The investigators will use logistic regression analysis to identify the independent association between OXTR DNA methylation and time spent with parent(s) and word count.

Read the detailed description

Student's t-test and Pearson's chi-square tests will be used to compare continuous and categorical variables, respectively. Logistic regression analysis will used to identify the independent association between OXTR DNA methylation and time spent with parent(s) and word count. Variables with p≤0.20 in the univariate analysis will be entered into a stepwise logistic multivariate regression model. Odds ratios with 95% confidence intervals will be calculated. p value of less than 0.05 will be considered statistically significant.

A protocol modification was submitted to and approved by the University of Virginia IRB due to slower than expected participant enrollment. The protocol was modified such that:

  • Enrollment of <33 week instead of <32 week infants was permitted
  • Enrollment was permitted through the first 2 weeks after birth instead of through the first 1 week after birth
Being tested
reading

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • readingBehavioural

    Mothers and, if desired, mother's partner will read to preterm infant as frequently and as much as they are able to. Reading is the intervention. The variable of interest is parents' and infants' change in salivary oxytocin receptor gene methylation (OXTRm) over time.

Study groups in NCT05412524
Study groupRoleWhat they receive
ReadingExperimentalMother and, if desired, mother's partner will read to infant for at least 15 minutes per week, but will be encouraged to read to infant as much as possible. Saliva will be collected from infants and parents for OXTRm assay at pre-specified time points, and at these time point parents will also complete standardized questionnaires including PSS-NICU, PROMIS depression, and PROMIS anxiety to assess parental mood and stress. Reading time will be measured with a reading log provided to the parents, as well as with a commercially-available LENA device to measure word count.
Receives: Behavioral: reading

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary oxytocin receptor gene DNA methylation (OXTRm)

    Salivary oxytocin receptor gene DNA methylation (OXTRm), change in time as related to amount of time parents spend reading to infant

    Measured: Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

Secondary outcomes (3)

  1. Parental stress

    Parental stress, as measured by PSS-NICU, and its correlation with amount of time parents spend reading to infants

    Measured: Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

  2. Parental depression

    Parental stress, as measured by the PROMIS depression short form, and its correlation with amount of time parents spend reading to infants

    Measured: Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

  3. Parental anxiety

    Parental stress, as measured by the PROMIS anxiety scale, and its correlation with amount of time parents spend reading to infants

    Measured: Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start23 Sep 2022
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Mothers and, if desired, mother's partner will read to preterm infant as frequently and as much as they are able to. Reading is the intervention. The variable of interest is parents' and infants' change in salivary oxytocin receptor gene methylation (OXTRm) over time.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412524
Sponsor's protocol ID
HSR220058
Status last verified
May 2023
First submitted
10 May 2022
Last updated
17 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perkeybile AM, Carter CS, Wroblewski KL, Puglia MH, Kenkel WM, Lillard TS, Karaoli T, Gregory SG, Mohammadi N, Epstein L, Bales KL, Connelly JJ. Early nurture epigenetically tunes the oxytocin receptor. Psychoneuroendocrinology. 2019 Jan;99:128-136. doi: 10.1016/j.psyneuen.2018.08.037. Epub 2018 Aug 31.

    PubMed 30227351

  • Caskey M, Stephens B, Tucker R, Vohr B. Adult talk in the NICU with preterm infants and developmental outcomes. Pediatrics. 2014 Mar;133(3):e578-84. doi: 10.1542/peds.2013-0104. Epub 2014 Feb 10.

    PubMed 24515512

  • Krol KM, Moulder RG, Lillard TS, Grossmann T, Connelly JJ. Epigenetic dynamics in infancy and the impact of maternal engagement. Sci Adv. 2019 Oct 16;5(10):eaay0680. doi: 10.1126/sciadv.aay0680. eCollection 2019 Oct.

    PubMed 31663028

  • Caskey M, Stephens B, Tucker R, Vohr B. Importance of parent talk on the development of preterm infant vocalizations. Pediatrics. 2011 Nov;128(5):910-6. doi: 10.1542/peds.2011-0609. Epub 2011 Oct 17.

    PubMed 22007020

  • Neri E, De Pascalis L, Agostini F, Genova F, Biasini A, Stella M, Trombini E. Parental Book-Reading to Preterm Born Infants in NICU: The Effects on Language Development in the First Two Years. Int J Environ Res Public Health. 2021 Oct 29;18(21):11361. doi: 10.3390/ijerph182111361.

    PubMed 34769878

Questions about this trial

What is this clinical trial studying?

A study testing reading in people with Premature Infant Disease and Development, Infant, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary oxytocin receptor gene DNA methylation (OXTRm) (time frame: Birth to discharge from neonatal intensive care unit (approximately 1-4 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412524, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.

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